MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL RADIUS VOLAR PLATE/SCREWS; PLATE, FIXATION ,BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Neuropathy (1983); Pain (1994); Joint Dislocation (2374); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Device report from synthese reports an event in norway as follows: this report is being filed after the review of the following journal article: eikrem m, et al.(2021), volar locking plate versus dorsal locking nail-plate fixation for dorsally displaced unstable extra-articular distal radial fractures, jbjs open access d 2021:e21.00068.Http://dx.Doi.Org/10.2106/jbjs.Oa.21.00068 (norway) the purpose of the present randomized controlled trial was to compare patient-reported outcomes as well as radiographic and functional results between patients who underwent stabilization with a volar locking plate or a dorsal locking nail-plate for the treatment of dorsally displaced unstable extra-articular distal radial fracture.Between april 2009 and december 2012, 120 patients with unstable dorsally displaced fracture of the distal radius without articular involvement or extension into the diaphysis (ao/ota type 2r3a2 or 2r3a31) were included in the study.The patients were randomly allocated with either an unknown synthes dvr volar locking plate or an unknown synthese dorsal locking nail plate.There were 60 patients in each group.In the volar plate group, there were 53 females and 7 males with a mean age of 66.5 +/- 7.8 years.In the dorsal nail-plate group, there were 56 females and 4 males with a mean age of 66.9+/-6.29 years.Patients in both groups received the same wound dressing and a wrist orthosis postoperatively.The orthosis was removed after 2 weeks but could be used intermittently until then if desired.Patients were assessed in the outpatient clinic at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year.Complications were reported as follows: (volar plate group) 3 patients had carpal tunnel syndrome and were reoperated.2 patients had local pain and underwent implant removal.1 patient underwent screw/peg removal due to misplacement.1 patient had scapholunate dissociation (untreated).1 patient had reactivated small-joint arthritis.1 patient had extensor carpi ulnaris tendinopathy.1 patient had trigger finger.1 patient had dupuytren contracture.(dorsal nail-plate group) 3 patients had carpal tunnel syndrome and were reoperated.1 patient had redisplacement and underwent secondary osteosynthesis.2 patients underwent screw/peg removal due to misplacement.2 patients had complex regional pain syndrome.1 patient had scapholunate dissociation (untreated).1 patient had radioulnar instability (untreated).1 patient had extensor carpi ulnaris tendinopathy.This report is for the unknown synthese constructs: lcp distal radius volar plate/screws.A copy of the literature article is being submitted with this regulatory report.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown constructs: lcp distal radius volar plate/screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL RADIUS VOLAR PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17070600
• MDR Text Key: 316750794
• Report Number: 8030965-2023-07123
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention